BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW

    MDR report key: 10313655 · Received July 23, 2020

    Report

    Report Number
    8030965-2020-05169
    Event Type
    Injury
    Date Received
    July 23, 2020
    Report Date
    July 3, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GARG B, ET AL (2011), OUTCOME OF SHORT PROXIMAL FEMORAL NAIL ANTIROTATION AND DYNAMIC HIP SCREW FOR FIXATION OF UNSTABLE TROCHANTERIC FRACTURES. A RANDOMIZED PROSPECTIVE COMPARATIVE TRIAL, HIP INT, VOLUME 21, PAGE 531-536, (INDIA) . THIS PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL WAS UNDERTAKEN TO COMPARE THE OUTCOMES FOLLOWING TREATMENT OF UNSTABLE PER TROCHANTERIC FEMORAL FRACTURES WITH EITHER A SHORT PROXIMAL FEMORAL NAIL ANTIROTATION OR A SLIDING HIP SCREW. BETWEEN APRIL 2007 AND MAY 2008, 81 PATIENTS WITH UNSTABLE FRACTURES OF THE PROXIMAL PART OF THE FEMUR WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMIZED, AT THE TIME OF ADMISSION, FOR FIXATION WITH EITHER AN UNKNOWN SYNTHES SHORT PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA GROUP) OR AN UNKNOWN SYNTHES DYNAMIC HIP SCREW (DHS GROUP). THE PFNA GROUP WAS COMPRISED OF 42 PATIENTS WITH 32 MALES AND 10 FEMALES WITH A MEAN AGE OF 60.2 YEARS (RANGE, 60 TO 80 YEARS). MEANWHILE, THE DHS GROUP WAS COMPRISED OF 39 PATIENTS WITH 27 MALES AND 12 FEMALES WITH A MEAN AGE OF 64.3 YEARS (RANGE, 60 TO 78 YEARS). AN UNKNOWN SYNTHES 135 DEGREES DYNAMIC HIP SCREW PLATE 4-HOLE TO 8 HOLES, DEPENDING ON THE DISTAL EXTENT OF THE FRACTURE, WERE USED IN THE DHS GROUP WHILE EITHER AN UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION COMPRESSION SCREW OR AN UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION HELICAL BLADE WERE USED IN THE PFNA GROUP. WEIGHT-BEARING, AS TOLERATED WITH A WALKER, WAS ADVISED IN ALL PATIENTS POSTOPERATIVELY. CLINICAL AND RADIOLOGICAL FOLLOW UP EVALUATIONS WAS UNDERTAKEN AT 3, 6, AND 12 MONTHS AND ANNUALLY THEREAFTER. THE MINIMUM FOLLOW-UP PERIOD FOR PATIENTS IN BOTH THE GROUPS WAS 36 MONTHS AND THE MEAN FOLLOW UP PERIOD WAS 40 MONTHS (36 TO 48 MONTHS). COMPLICATIONS WERE REPORTED AS FOLLOWS: (DHS GROUP). 6 PATIENTS HAD CUT THROUGH OF THE IMPLANT FROM THE FEMORAL HEAD WITH VARUS COLLAPSE AND REQUIRED REVISION. 1 OF THESE PATIENTS HAD A SCREW CUT THROUGH AT 8 MONTHS POST-OP. 1 PATIENT HAD A VARUS COLLAPSE OF THE FEMORAL HEAD WITH SCREW CUT THROUGH AT 6 MONTHS POST-OP. 1 PATIENT DIED AT THE END OF THE FIRST POSTOPERATIVE YEAR. 2 PATIENTS DIED AT THE END OF THE SECOND POSTOPERATIVE YEAR. (PFNA GROUP) 1 PATIENT DIED AT THE END OF THE FIRST POSTOPERATIVE YEAR. 3 PATIENTS DIED AT THE END OF THE SECOND POSTOPERATIVE YEAR. 1 PATIENT DIED AT THE END OF THE THIRD POSTOPERATIVE YEAR. THIS REPORT IS FOR AN UNKNOWN SYNTHES 135 DEGREE DYNAMIC HIPS SCREW PLATE, UNKNOWN SYNTHES DYNAMIC HIP SCREW LAG SCREW, UNKNOWN SYNTHES SCREWS, AND UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION. THIS REPORT IS FOR ONE (1) UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780029 UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention